European EMC compliance i.e. CE marking is a self-declaration process. This process involves maintaining evidence of compliance with the accepted published dated version of the standards as per the EMC directive. EN 61326-1 & EN 61326-2-6 changes impact on CE declarations made by your company.
CE EMC directive
The new EMC directive 2014/30/EU came into force in April 2016 and requires compliance with updated revisions of applicable EMC standards. These standards may include the following, depending on your product:
EN 61326-1:2013 (IEC 61326-1:2012)
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements
So knowing that you should be making your self-declaration based on evidence or engineering knowledge lets examine what impact the revision of EN 61326-1 has upon the previous testing in accordance with EN 61326-1: 2006. Let’s have a look at the impact of the changes between EN 61326-1: 2006 and EN 61326-1: 2013. We will break it down into sub-sets of emissions and immunity testing requirements.
CISPR 11 dated references were changed from CISPR 11: 2003 to CISPR 11: 2009 version of CISPR 11, including the 2010 amendment. The main change with the CISPR 11 update was that it allowed small products to be tested at a 3m measuring distance for Radiated emissions (30MHz to 1GHz) as opposed to the previously stated 10m measuring distance. Please see our other blog post for further information regarding Radiated emissions test site measuring distances.
Updated references for Harmonics and Flicker testing (EN 61000-3-2 & EN 61000-3-3) changes impacts. No significant changes that would affect this type of equipment, for further information please refer to the link. Note, only required for products that must meet Class B (residential) limits.
The majority of the immunity testing references such as EN 61000-4-2, EN 61000-4-3, EN 61000-4-4, EN 61000-4-5, EN 61000-4-6 and EN 61000-4-8 have all been updated. Most of the changes should not affect the compliance of the product, provided the original testing was performed correctly.
One change that may pose a low risk (provided the testing was originally conducted in a competent EMC testing laboratory) was the magnetic immunity test method change for tabletop equipment. The change is a minor and the magnetic field is only 3A/m which could affect susceptible equipment thus most products won’t be affected by this. Also, remember that the testing should have been performed to both 50 and 60Hz for the latest version, so it may require re-testing if you feel the need to do so.
Performance criteria for immunity testing
A more comprehensive Performance Criteria definition has been included. For Performance Criteria A & B. EN61326-1: 2013 version has added the wording “permissible loss of performance” this allows manufacturers to state a pass despite an immunity test failure. However this is only provided the manufacturer defines this in their user’s manual or product documentation, it goes without saying this should also appear in the EMC test report.
Performance Criterion C is basically the same. With the user, intervention is still allowed if required for re-established product functionality. Provided that there is no permanent damage and the user can recover full functionality.
EN 61326-1 defines the immunity testing requirements for different intended environments of use, these different locations include:
- Controlled Electromagnetic (EM)
- Portable Test and Measurement (in Annex A of the standard)
For products that were tested in accordance with the older version of the standard i.e. EN 61326-1: 2006 the changes that will affect your compliance as follows:
‘Basic’ environment immunity changes
The Electrostatic Discharge (ESD) in accordance with the basic methods of EN 61000-4-2 has changed the test level requirement for air discharge, it has been increased from +/- 4Kv to +/- 8kV.
A power frequency H-field (magnetic immunity) requirement of 3 A/m is required to be performed at both 50 & 60 Hz. Previously there was no requirement to perform this test in EN 61326-1: 2006. This only applies to “magnetically sensitive equipment”.
‘Industrial’ environment immunity changes
There are no significant changes in immunity testing requirements for ‘Industrial’ environments. The power frequency H-field (magnetic immunity) requirement now specifies both 50 and 60Hz.
‘Controlled EM’ environment immunity changes
The testing requirements relating to the port described as the “Measurement I/O” port category was deleted.
‘Portable Test and Measurement’ environment immunity changes
A power frequency H-field (magnetic immunity) requirement of 3 A/m is required to be performed at both 50 & 60 Hz. Previously there was no requirement to perform this test in EN 61326-1: 2006. This only applies to “magnetically sensitive equipment”. The addition of performance criteria for the applicable EMC immunity testing has now been included.
CE In Vitro Directive
The current ‘In-Vitro Diagnostics Directive 98/79/EC’ will be replaced by a New Legislative Framework (NLF) Regulation probably between 2017 and 2021. Currently, the listed OJEU version is EN 61326-2-6: 2006.
EN 61326-2-6:2006 (IEC 61326-2-6:2005)
Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment.
However, there is a newer published version of the standard. Looking forward to providing long-term compliance it may be beneficial to test in accordance with EN 61326-2-6:2013. Some of the changes are listed below:
Reference updates including the reference of EN 61326-1: 2006 replaced with the EN 61326-1: 2013 which will include all the changes as described above. Also, ISO 14971 (risk analysis and assessment) has been updated from the 2000 version to the 2007 edition.
EN 61326-2-6: 2013 requires Electromagnetic field immunity testing (radiated immunity) has been extended to include testing from 2GHz to 2.7GHz.
As such compliance to EN 61326-2-6: 2013 could be used to demonstrate compliance to EN 61326-2-6: 2006 but not the other way round.